Factors Determining Tolerance to Nasal Allergen Exposure With Advanced Age in a Subset of Birch Pollen Allergic Subjects

NCT06459219 | Not Yet Recruiting

• 1 other identifier: AllergyAge
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

Nasal allergen study in patients aged 60+ with or without current respiratory allergy

Conditions

Allergic Rhinitis; Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (1)

• Nasal IgG4

  To demonstrate that Bet v 1-specific nasal IgG4 responses 5 weeks after controlled nasal birch pollen provocation are significantly higher in subjects aged ≥60y without ongoing respiratory allergic symptoms with a history of allergy (group1) as compared to age-matched subjects currently suffering from allergic rhinoconjunctivitis (group 2).

  5 weeks

Study Arms (3)

Ongoing (symptoms min 3 years)

Ongoing intermittent allergic rhinoconjunctivitis to birch pollen with moderate to severe symptoms according to ARIA guidelines for at least 10 years Positive Skin prick test (SPT) to birch pollen and/or Bet v 1-specific IgE ≥0.35kUA/L as measured by ImmunoCAP ≥60 y

Previous (no symptoms past 3 years)

History of intermittent allergic rhinoconjunctivitis to birch pollen ongoing with moderate to severe symptoms according ARIA guidelines26 for at least ten years (verified by at least one medical record including SPT results), but no symptoms for at least the three past consecutive seasons Positive or negative SPT to birch pollen and Bet v 1-specific IgE ≤ or ≥0.35kUA/L as measured by ImmunoCAP ≥60 y

No (never symptoms)

No history of and no ongoing allergic rhinoconjunctivitis to birch pollen Negative SPT to birch pollen and Bet v 1-specific IgE ≤ 0.35kUA/L ≥60 y

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged ≥ 60 years with or without current or former allergy

You may qualify if:

• Group 1 (current allergy):
• Ongoing intermittent allergic rhinoconjunctivitis to birch pollen with moderate to severe symptoms according to ARIA guidelines for at least 10 years Positive Skin prick test (SPT) to birch pollen and/or Bet v 1-specific IgE ≥0.35kUA/L as measured by ImmunoCAP
• Group 2 (former allergy):
• History of intermittent allergic rhinoconjunctivitis to birch pollen ongoing with moderate to severe symptoms according ARIA guidelines for at least ten years (verified by at least one medical record including SPT results), but no symptoms for at least the three past consecutive seasons Positive or negative SPT to birch pollen and Bet v 1-specific IgE ≤ or ≥0.35kUA/L as measured by ImmunoCAP
• Group 3 (never allergy):
• No history of and no ongoing allergic rhinoconjunctivitis to birch pollen Negative SPT to birch pollen and Bet v 1-specific IgE ≤ 0.35kUA/

You may not qualify if:

• \- Evidence of acute, chronic, malignant or general diseases-assessed by asking the patient
• A History of anaphylaxis
• Utilization of leukotriene modifiers or long-acting antihistamines
• Chronic or intermittent use of oral, inhaled, intramuscular or intravenous corticosteroids
• Nasal polyps, history of chronic sinusitis or considerable deviation of the nasal septum
• Rhinitis secondary to other causes
• Contra-indications to skin prick testing, for example, skin irritation in the test area and urticaria facticia
• Cardiovascular diseases requiring treatment with anti-hypertensive medication or beta-blockers
• Known clotting disorders
• Chronic use of additional medications that would affect assessment and the results of the study (e.g., tricyclic antidepressants that block both H1 and H2 receptors)
• Pregnant or breastfeeding females
• Actual disability that would influence subject's ability to participate in the study
• History of mental illness, intellectual deficiency, drug or alcohol abuse
• Active asthma requiring treatment
• Allergen immunotherapy within the last 5 years to any allergen

Sponsors & Collaborators

• Sven Schneider, MD: lead

Study Sites (1)

Medical University of Vienna

Vienna, Austria, A-1090, Austria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, Nasal secretions, nasal biopsies

MeSH Terms

Conditions

Rhinitis, Allergic; Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Conjunctivitis; Conjunctival Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 14, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

AU (1)